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Orion Corporation has withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease
Espoo, Finland | October 21, 2009 | Orion Corporation has withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease. The withdrawal is based upon Orion's assessment of findings from clinical studies with Stalevo, i.e. FIRST-STEP and STRIDE-PD, which indicate that Stalevo does not provide a consistent risk/benefit profile for the early Parkinson's disease patient population at the dosing regimen tested. In early March 2009, Orion withdrew the corresponding EU application.
In the USA, Stalevo is currently indicated to treat patients with idiopathic Parkinson's disease to substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual products and to replace immediate-release carbidopa/levodopa when certain patients experience the signs and symptoms of end-of-dose "wearing-off".
About Orion
Orion is an innovative European, R&D-based, pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients as well as diagnostic tests. Orion's pharmaceutical R&D focuses on developing medicines for the central nervous system diseases, critical care and oncology as well as inhaled products for the Easyhaler® platform.
The Group's net sales in 2008 amounted to EUR 711 million and the company invested EUR 90.0 million in research and development. At the end of 2008, the Group had a total of 3,300 employees, of whom 2,700 worked in Finland and the rest 600 in other European countries. Orion's Shares A and B are both listed on the NASDAQ OMX Helsinki. For more information, please visit: http://www.orion.fi/english/.
SOURCE: Orion Corporation |
